MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LIFEBAND; CARDIAC RESUSCITATOR BAND

Model Number MODEL 100

Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2023

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the lifeband in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

The autopulse platform sn (b)(4) was used to resuscitate a patient in cardiac arrest.The customer reported that the autopulse platform initially performed about two minutes of compressions, and then it paused and displayed the prompt, "realign patient".The customer stated that the platform showed an error message at the start but didn't recall the error code.While re-positioning the patient on the platform, the crew attempted to remove the patient's clothing, which had been previously cut before placing the patient on the platform.The lifeband (lot # unknown) became entangled with the patient's clothing, causing the lifeband to become jammed.The crew removed the patient from the platform.The customer noticed that the lifeband belt clip was damaged and stuck into the platform driveshaft slot, preventing the insertion of a new lifeband.Eventually, the customer removed the broken belt clip and inserted a new lifeband (lot # unknown).The customer stated that during deployment with the replacement lifeband, it felt that the lifeband was loosely connected to the platform and kept slipping.The customer felt the lifeband was not tight enough around the chest during periods of decompression.As per the customer, the platform was not performing as intended.Also, it was reported that the autopulse platform was making a loud noise during use.The crew reverted to manual cpr but discontinued resuscitation soon after.The patient's status information was requested, but the customer did not provide a response.Please see the following related mfr reports: mfr # 3010617000-2023-00164 for the autopulse platform (sn (b)(4).Mfr # 3010617000-2023-00249 for lifeband (lot # unknown).

Event Description

The autopulse platform ((b)(4)) was used to resuscitate a patient in cardiac arrest.The customer reported that the autopulse platform displayed an error message at the initial power-up of the device but didn't recall the error code.After powering off and on the autopulse, the error was cleared.The platform performed about two minutes of compressions before it stopped and displayed the prompt, "realign patient." while re-positioning the patient on the platform to troubleshoot the issue, the crew attempted to remove the patient's clothing, which had been previously cut before placing the patient on the platform.The lifeband became entangled with the patient's clothing, causing the lifeband to become jammed.The crew removed the patient from the platform.They noticed that the lifeband belt clip was damaged and stuck into the platform driveshaft slot, preventing the insertion of a new lifeband.Eventually, the crew removed the broken belt clip and inserted a new lifeband.The customer stated that during deployment with the replacement lifeband, it felt that the lifeband was loosely connected to the platform and kept slipping.Also, the crew reported that the autopulse platform was making loud clicking noises during operation.The customer felt the lifeband was not tight enough around the patient's chest during periods of decompression, and the platform was not performing as intended.The crew reverted to manual cpr but discontinued it because the patient was experiencing protein-losing enteropathy (ple) and needed extra care.Per the customer, there was no adverse impact on the patient due to the reported issue.

Manufacturer Narrative

B5 (describe event or problem) was updated based on the received additional information.D9 (returned to manufacturer) was updated based on the received additional information.H6 (health effect - clinical code) was corrected based on the received additional information.H6 (health effect - impact code) was corrected based on the received additional information.H6 (type of investigation) was corrected based on the received additional information.The lifeband associated with this complaint was discarded by the customer.Since the device was not returned, an investigation could not be performed and a root cause could not be determined.

• Brand Name: AUTOPULSE® LIFEBAND
• Type of Device: CARDIAC RESUSCITATOR BAND
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 16394751
• MDR Text Key: 309758615
• Report Number: 3010617000-2023-00228
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0701-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1